Breast Cancer (Locally Advanced or Metastatic)ASSISTNCT07553572
Remote Monitoring and Symptom Management Digital Application
A study testing ASSIST phone application in people with Breast Cancer (Locally Advanced or Metastatic) and Lymphoma, run by Patrick C. Johnson, MD at 1 site in United States.
Trial summary
The goal of this clinical trial is to learn if an artificial intelligence phone application called ASSIST can help patients receiving cancer treatment. The main question[s] it aims to answer are: Is ASSIST feasible for patients (meaning can it be used by patients)? Is ASSIST acceptable to patients (meaning do patients… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Breast Cancer (Locally Advanced or Metastatic), Lymphoma, Colorectal Cancer
- What is being tested?
- ASSIST phone application
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Apr 2026to 31 Mar 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18 years or older
- Ability to understand English
- About to begin definitive systemic treatment (or within 4 weeks of beginning treatment) based upon the oncology treatment intent form for a new diagnosis of breast cancer, colorectal cancer, or lymphoma.
- Expected treatment duration of at least 12 weeks
- Own or willing to receive a smartphone
Who cannot join
- Cognitive impairment that would interfere with ability to use smartphone application (as assessed by their attending physician)
- Visual or motor impairment that would prevent smartphone use
- Expected survival less than 3 months
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Massachusetts General Hospital
Boston, Massachusetts, 02114
Patrick C Johnson, MD, 6177244000, pcjohnson@mgh.harvard.edu
About this study
Official title: Pilot Randomized Controlled Trial of a Remote Monitoring and Symptom Management Intervention (ASSIST) Among Patients Receiving Systemic Therapy
The goal of this clinical trial is to learn if an artificial intelligence phone application called ASSIST can help patients receiving cancer treatment.
The main question[s] it aims to answer are:
Is ASSIST feasible for patients (meaning can it be used by patients)? Is ASSIST acceptable to patients (meaning do patients like it)?
Researchers will compare the ASSIST phone application to see how it compares to usual clinical care.
Participants on the ASSIST arm will use the ASSIST phone application for 12 weeks, and participants in both groups will complete surveys.
- Being tested
- ASSIST phone application
- Medical subject headings
- Breast Neoplasms, Neoplasm Metastasis, Lymphoma, Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ASSIST phone applicationOther
The intervention consists of a smartphone-based application that provides personalized support using AI during cancer treatment. Patients will also receive standard care from their oncology team, including routine symptom management and supportive care measures.
| Study group | Role | What they receive |
|---|---|---|
| ASSIST phone application arm | Experimental | The intervention consists of a smartphone-based application that provides personalized support using AI during cancer treatment. Patients will also receive standard care from their oncology team, including routine symptom management and supportive care measures. Receives: Other: ASSIST phone application |
| Usual Care | No intervention | Patients in the usual care group will receive standard care from their oncology team, including routine symptom management and supportive care measures. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recruitment Rates
We will deem the intervention feasible if recruitment rates achieve ≥ 60% of eligible patients
Measured: From enrollment to end of intervention at 12 weeks
Percentage of participants using the digital application once per week in at least 7/12 weeks
The intervention will be feasible if among those enrolled and randomized to the intervention arm, ≥ 60% use ASSIST once per week in at least 7/12 weeks.
Measured: From enrollment to end of intervention at 12 weeks
Secondary outcomes (1)
Acceptability
The intervention will be deemed acceptable if ≥ 80% of patients on the ASSIST intervention arm report satisfaction based on a rating of "Somewhat satisfied" or "Very satisfied" when asked about their experience with the intervention.
Measured: From enrollment to the end of the intervention at 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2026
- Study start14 Apr 2026
- Primary completion30 Nov 2026 (estimated)
- Study completion31 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast Cancer (Locally Advanced or Metastatic)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Patrick C. Johnson, MD
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Patrick C. Johnson, MD, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07553572
- Sponsor's protocol ID
- 25-739
- Acronym
- ASSIST
- Status last verified
- Apr 2026
- First submitted
- 14 Apr 2026
- Last updated
- 28 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Randomized Controlled Trial of a Remote Monitoring and Symptom Management Intervention (ASSIST) Among Patients Receiving Systemic Therapy
- ClinicalTrials.gov ID
- NCT07553572
- Acronym / sponsor ID
- ASSIST / 25-739
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Patrick C. Johnson, MDUniversity, hospital or other
- Study start
- 14 Apr 2026 (actual)
- Primary completion
- 30 Nov 2026 (estimated)
- Study completion
- 31 Mar 2027 (estimated)
- First posted
- 28 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this clinical trial is to learn if an artificial intelligence phone application called ASSIST can help patients receiving cancer treatment.
The main question[s] it aims to answer are:
Is ASSIST feasible for patients (meaning can it be used by patients)? Is ASSIST acceptable to patients (meaning do patients like it)?
Researchers will compare the ASSIST phone application to see how it compares to usual clinical care.
Participants on the ASSIST arm will use the ASSIST phone application for 12 weeks, and participants in both groups will complete surveys.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ASSIST phone application arm | Experimental | Other: ASSIST phone applicationThe intervention consists of a smartphone-based application that provides personalized support using AI during cancer treatment. Patients will also receive standard care from their oncology team, including routine symptom management and supportive care measures. |
| Usual Care | No intervention | –Patients in the usual care group will receive standard care from their oncology team, including routine symptom management and supportive care measures. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age 18 years or older
- Ability to understand English
- About to begin definitive systemic treatment (or within 4 weeks of beginning treatment) based upon the oncology treatment intent form for a new diagnosis of breast cancer, colorectal cancer, or lymphoma.
- Expected treatment duration of at least 12 weeks
- Own or willing to receive a smartphone
Key exclusion criteria (3 listed)
- Cognitive impairment that would interfere with ability to use smartphone application (as assessed by their attending physician)
- Visual or motor impairment that would prevent smartphone use
- Expected survival less than 3 months
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ASSIST phone applicationThe intervention consists of a smartphone-based application that provides personalized support using AI during cancer treatment. Patients will also receive standard care from their oncology team, including routine symptom management and supportive care measures. | Other | ASSIST phone application arm |
Primary outcome
Recruitment Rates
Time frame: From enrollment to end of intervention at 12 weeks
We will deem the intervention feasible if recruitment rates achieve ≥ 60% of eligible patients
Percentage of participants using the digital application once per week in at least 7/12 weeks
Time frame: From enrollment to end of intervention at 12 weeks
The intervention will be feasible if among those enrolled and randomized to the intervention arm, ≥ 60% use ASSIST once per week in at least 7/12 weeks.
1 secondary outcome
Acceptability
Time frame: From enrollment to the end of the intervention at 12 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Apr 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ASSIST phone application in people with Breast Cancer (Locally Advanced or Metastatic) and Lymphoma, run by Patrick C. Johnson, MD at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 28 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Patrick C Johnson, MD (6177244000, pcjohnson@mgh.harvard.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recruitment Rates (time frame: From enrollment to end of intervention at 12 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Apr 2026.